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Purpose

A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy. 2. Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.

Exclusion Criteria

  1. Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity. 2. Planned epilepsy surgery during the course of the clinical trial. 3. History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment or vagus nerve stimulation (VNS) implantation. 4. History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders. 5. History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded. 6. History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies). 7. Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening. 8. Is pregnant or is breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose. 9. Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Randomized, Double-Blind 20mg/day for 6 weeks then 30mg/day for remaining 6 weeks PRAX-628 		Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive 20 mg of PRAX-628 for 6 weeks followed by 30 mg PRAX 628 for the remaining 6 weeks.
  • Drug: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
    Once daily oral
Experimental
Randomized, Double-Blind Placebo 		Participants who meet all eligibility criteria will be randomized at Visit 1 (Day 1) to receive a matching placebo throughout the 12-week Treatment Period
  • Drug: Placebo
    Once daily oral

Recruiting Locations

Praxis Research Site
Phoenix 5308655, Arizona 5551752 85032

Praxis Research Site
DeLand 4152890, Florida 4155751 32720

Praxis Research Site
Miami Lakes 4164186, Florida 4155751 33016

Praxis Research Site
Chicago 4887398, Illinois 4896861 60640

Praxis Research Site
Lafayette 4330145, Louisiana 4331987 70508

Praxis Research Site
Bethesda 4348599, Maryland 4361885 20817

Praxis Research Site
Chesterfield 4381072, Missouri 4398678 63005

Praxis Research Site
Ozark 4402245, Missouri 4398678 65721

Praxis Research Site
Hackensack 5098706, New Jersey 5101760 07601

Praxis Research Site
Middletown 5126842, New York 5128638 10940

Praxis Research Site
Canton 5149222, Ohio 5165418 44718

Praxis Research Site
Oklahoma City 4544349, Oklahoma 4544379 73112

Praxis Research Site
El Paso 5520993, Texas 4736286 79912

Praxis Research Site
Frisco 4692559, Texas 4736286 75034

Praxis Research Site
Round Rock 4724129, Texas 4736286 78681

Praxis Research Site
Seabrook 4727596, Texas 4736286 77586

More Details

NCT ID
NCT06999902
Status
Recruiting
Sponsor
Praxis Precision Medicines

Study Contact

Head of Pharmacovigilance
617-300-8460
clinicaltrials@praxismedicines.com

Detailed Description

PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center